OBJECTIVES:

The objectives of this study were to assess trends in the median HIV ARV drug prices per DDD in the US in the period 1987-2015 and to compare the AWP and the NADAC for HIV ARV

METHODS:

The list of HIV ARV drug marketed in the US was extracted from the FDA website. We used the World Health Organization Anatomical Therapeutic Chemical (ATC) classification system website to collect defined daily dose (DDD) for each HIV ARV drug. We used the RedBook to collect the WAC and the AWP. The AWP were collected from approval date to deactivation date or December 31, 2015. We used the consumer price index-all urban consumers (CPI-U) to convert prices to 2015 US dollars. Descriptive analysis was performed.

RESULTS:

In the period 1987-2015, the FDA had listed 39 ARV drugs with 48 different pharmaceutical dosage forms and strengths approved in the US. The market entry inflation-adjusted AWP per DDD was $28.59 for zidovudine, the first HIV ARV that was approved in 1987. The lowest market entry inflation-adjusted AWP per DDD was $5.13 for lopinavir/ritonavir in 2000 and the highest was $102.97 for (cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide) in 2015. The median market entry inflation-adjusted AWP per DDD was $28.59 (interquartile range [IQR]=$12.20) for HIV ARV drugs approved in the 1980s, $13.80 (IQR=$17.60) in the 1990s, $20.60 (IQR=$19.50) in the 2000s, and $39.04 (IQR= $24.04) in the period 2010–2015. The NADAC represented on average 75.2% of the AWP, with a range from 64.5% (ritonavir, 100 mg) to 95.9% (efavirenz/emtricitabine/tenofovir disoproxil fumarate, tab, 600 mg-200 mg-300 mg).

CONCLUSIONS:

The prices of new HIV ARV drugs at market entry increased over time. The prices of existing drugs increased faster than the inflation rate. The high prices of HIV ARV drugs may impact affordability and accessibility to critical medications for both insured and uninsured population groups.